# China NMPA Product Recall - Computed Tomography X-ray Imaging Reader System

Source: https://www.globalkeysolutions.net/records/china_product_recall/suzhou-fujifilm-imaging-equipment-co-ltd/d5da583a-fdd2-4da4-88aa-229e3d517624/
Source feed: China

> China NMPA product recall for Computed Tomography X-ray Imaging Reader System by Suzhou Fujifilm Imaging Equipment Co., Ltd. published January 12, 2017. Recall level: Level 3 Recall. Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a Class III voluntary recall of its Computed T

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Suzhou Fujifilm Imaging Equipment Co., Ltd. is voluntarily recalling its computed tomography (CT) X-ray imaging reader system.
- Company Name: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Publication Date: 2017-01-12
- Product Name: Computed Tomography X-ray Imaging Reader System
- Recall Level: Level 3 Recall
- Recall Reason: The DQE value of this product does not meet the company's specifications registered with the JSFDA, but it meets the company's uniform specifications for global sales, and no injury incidents have occurred to date.
- Discovering Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Manufacturing Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Summary: Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a Class III voluntary recall of its Computed Tomography (CT) X-ray Imaging Reader Systems, including models FCR CAPSULA XLII and FCR CAPSULA X, around January 2017. The recall, reported to the National Medical Products Administration (NMPA), was prompted by a critical deviation where the Quantum Detection Efficiency (DQE) value, a key measure of image quality, did not comply with the specifications registered with the JSFDA. Although the products met Fujifilm's unified global sales specifications, they failed to meet the specific national registration requirements. There have been no reported injuries associated with this issue. A total of four affected units were identified in Mainland China. As part of the required actions, three unsold units held in Fujifilm (China) Investment Co., Ltd.'s warehouse are to be returned to the factory for necessary repairs and re-inspection. Additionally, one unit that had already been installed and was in use at a hospital is mandated to be isolated and subsequently disposed of. This action ensures compliance with national medical device standards and addresses the discrepancy in product performance.

Company: https://www.globalkeysolutions.net/companies/suzhou-fujifilm-imaging-equipment-co-ltd/05879a2b-0ed5-4e2a-be94-59a6db3bddf7/